Animal health diagnosis

ABSTRACT

Laboratory test data are analyzed in relation to the health assessment data of an animal together with the genetic data related to that same animal. These data are relevant to the likely morbidity, likely longevity, and/or the potential risk for disease or disorder for the animal, including temperament, immune stimulation and cellular inflammatory response mediators, markers for neoplastic or paraneoplastic change, inherited organ dysfunction or dysplasia, autoimmune thyroiditis, mammary cancer, immune surveillance markers, and inherited bleeding tendency. A panel of tests relates to at least one of endocrine function, immunologic function, gastrointestinal function and nutritional analysis, inborn errors of metabolism, paternity, DNA fingerprinting, hemostasis and coagulation function, vaccinal antibody status, adverse and potential adverse vaccine reaction, infectious diseases, pathology, blood typing and bone marrow analysis, cell cytotoxicity, cytokine and allergy testing, and markers of neoplastic and paraneoplastic change.

RELATED APPLICATION

This application relates to application Ser. No. 09/419,192 (Dodds)entitled Animal Genetic And Health Profile Database Management, andfiled Oct. 15, 1999, the contents thereof are incorporated by referenceherein.

TECHNICAL FIELD

This invention is concerned with animal health diagnosis. Moreparticularly the invention is directed to the testing, diagnosis andprediction of diseases and disorders of animal companions, for instancedogs and cats.

Further this invention relates to a method, system and apparatus for themanagement of comprehensive and cumulative genetic and health assessmentdatabases in relation to animals worldwide. In particular, the inventionrelates to a bioinformatics system and its implementation in relation toanimal biological data.

BACKGROUND OF THE INVENTION

Breeders, owners, and caregivers of animals which can be companions,such as dogs, cats, horses, farm, food, or zoo animals, and wildlife,have a need to understand their physical and biological attributes,genetic makeup, heritable disease, and disorder background, andlongevity.

Substantial investments in time, effort and financial resources are madeby the breeders, owners, and caregivers of these animals, particularlypurebred animals, to characterize their health state and predict theirmorbidity, mortality and longevity. Resources are separately directed toobtaining information about their genetic background. There is also aneed to conduct periodic comprehensive health assessments of animals.

The probability that an individual animal will develop a specifichealth-related condition in its lifetime is a product of complexinteractions between its genetic makeup, environmental influencesincluding diet, and agents of disease (e.g., chemical, physical, orbiological) that it encounters. Perhaps the best indicator of overallhealth of an individual animal or breed is longevity.

The physical attributes, and other descriptve and health assessmentinformation is generally termed in this application as the phenotypicinformation. Genetic disorder information is termed in this applicationas the genotypic information. Generally, these are two distinct anddiffering sets of information.

Phenotype Data

The physical descriptive and health assessment profiles includecharacteristics such as the physiological, pathological,endocrinological, hematological, epidemiological, behavioral, andimmunological data from parameters such as phenotype, breed, lifespan,health history, and presence of infectious diseases and metabolicdisorders. All of this is part of the phenotypic information. A healthassessment profile of an animal typically relates to a particularsubject of the group, as opposed to the group of animals as a whole.Generally, the phenotype is the genetic nature of an organism that isrevealed by visible characteristics or measurable performance, incontradistinction to the genotype, which may not be evident without abreeding test or genetic map.

Laboratories having a central database processing resource (CDPR) aswell as in-office laboratory equipment at veterinary hospitals orclinics are used for analyzing blood and other biological samples of asubject animal. This is a system for obtaining the phenotypicinformation. Communication systems are known for connecting theselaboratories with veterinary clinics through a telephone and/or faxconnection on an automated basis. These systems permit the veterinarian,animal hospital, or other authorized person (collectively orindividually termed the “remote user”) to receive the health assessmentprofile and basic descriptive identifying data, namely phenotypicinformation, of a subject animal from the CDPR. Until recently, it wasnot possible for the remote user to access the CDPR directly to obtainthis phenotypic information of a subject animal.

It is known for the breeder and/or owner of animals, such as purebredcompanions in the nature of dogs, cats, and horse, or animals of mixedbreeding, to obtain health assessments of their animals. The ownersobtain these data by submitting blood or other body fluid and tissuesamples of their animals, usually through a veterinarian or veterinaryclinic, to a laboratory for analysis of the biological, physiological,or pathological condition, namely the physical health of the animal.These data are then reported to the owner through the veterinarian orveterinary clinic. The data also can be stored on the CDPR of thelaboratory. Additionally, for each subject animal, the phenotypic datacan be stored on a computer storage system at the veterinary clinic orin a computer storage system of the owner and/or breeder. The retrievalof the data can be electronically, by voice, hard copy, or fax asrequired.

Seeking, obtaining and storing this phenotypic information is driven bythe needs of the animal breeder, owner or the agent of the owner and theanimal's healthcare provider. This information is of a nature that it isthe primary information sought to resolve the clinical, diagnostic,management, and therapeutic needs of an animal subject when the animalis in need of periodic wellness examination, is ill, or is to berestored to a well condition. These data are the essential informationresorted to by the clinician in the care of animals.

Genotype Data

The genotypic information relates to genetic mapping, geneticbackground, and genetic screening databases. This includes data obtainedfrom the pedigree, family history, heritable physical characteristics,genetic screening tests, DNA testing, genomic mapping, and relatedlaboratory assessment of the gene product for known or suspectedcongenital and heritable traits. In this application, the term “geneproduct” means the specific phenotypic characteristic(s) resulting fromthe expression of the genotype, and may include certain specificlaboratory test data.

This second aspect of data associated with the animals is the genetic orgenotype data or information. These data are typically used to estimatethe presence and prevalence of disease or disorder among differentbreeds or kinds of animals. These data are currently available on someselect clinical research databases, in book form, hard copy, or ingenetic disease registries.

When retained in a genetic disease registry, the data typically listonly those animals that are not affected with or carrying the heritabletrait in question. The abnormal or non-normal conditions (affected withor carriers of the heritable trait) are normally the subject ofconfidential knowledge of a breeder and/or owner, and not the subject ofa generally accessible database. This is retained as confidential by theowners either for financial reasons, risk reasons, legal liabilityreasons, or personal reasons.

The genotypic information typically relates to-individual animals, or agroup or class of animals and is most often stored manually in anon-CDPR facility. It is not typically stored by veterinarians in aclinical setting, since the genotypic data is a specialist form of dataused mainly for cataloging and research of diseases and disorders amonganimals. It is also not generally available for access to assist in theclinical analysis, diagnosis, and therapeutic management of animals.

This genotypic information, namely the physical characteristics andgenetic makeup pedigree), heritable disorder history, and related healthhistory of animals in the group is usually manually recorded bybreeders, owners, and researchers of companion and other valued animals.The genetic constitution of an organism includes genes without visibleeffects as well as those revealed by the phenotype. It may refer to allthe genes or to a single pair of alleles. The genotypic information istransmitted manually to and from persons or local and national genotypicdatabases maintained for specific disorders, and designed to fosterresearch into diseases and disorders, rather than being readilyaccessible to users for clinical purposes in the manner of phenotypicdata on a CDPR.

Some of the genetic data are available on registries related to specificdiseases or disorders, for instance, hip dysplasia, eye conditions,thyroid conditions, and blood conditions. Such disease-specificregistries are usually set up either by identifying affected animalbreeds, or are indexed by disease or disorder. The genetic informationdatabases are generally closed (kept confidential), but in some casesmay be open to researchers or members of groups, associations, andclubs.

Failings of the Existing Systems

To promote better health among animals, which can be animal companions,sport animals, farm animals, and the like, such as canine, feline,equine, bovine, porcine, caprine, ovine, and zoo animals or wildlife, itis important to secure accessible genotypic or genetic informationdatabases. It is also important to be able to relate these genotypicdatabases to the health assessment profiles or phenotypic databases ofparticular subject animals.

Many purebred animals are valuable, and so it is important to obtaintheir descriptive phenotypic information, and periodic health assessmentdata throughout their lives, and also to incorporate their genotypicinformation in order to promote and maintain effective high quality andhealthy breeding stock, and maximize their lifespan. The phenotype datafor an animal include the health assessment profile, breed, and thephysical characteristics of the animal. The genotype data include thegenetic map, pedigree, family history, genetic screening tests, anddisorder and disease characteristics of a particular animal, animalfamily, line, or group of animals.

There is a need to develop these data in a cumulative, comprehensive,and dynamic system of database management to thereby enhance the healthpredictability, and longevity of animals.

This type of comprehensive and cumulative database on individual orgroups of animals needs to be preserved and shared locally, regionally,nationally, and globally. A mechanism to do this is presently not knowndue to the various constraints surrounding each of the two types ofdatabases. The phenotype database storage, use, and access is fashioned,formed and structured for use by clinical laboratories andveterinarians. The genotype information is fashioned and structuredgenerally for clinical research and breeder/owner uses as opposed toclinical medical uses.

It is not known to store and/or present phenotypic information andgenotypic information as a comprehensive and cumulative assessment ofindividual animal subjects, families of subjects, breeds of subjects, orspecies of animals in a computerized format which is available throughcomputer networlding to authorized remote users.

Accordingly, there is a need to relate different databases from animals,animal groups or species, in a manner to permit enhancement of theanimal kingdom for breeding and growth in a healthy manner with aminimum of disease (reduced morbidity and mortality) and increasedlongevity.

As the above demonstrates, there is a need for a new database managementbioinformatics scheme and relational database, together withcomputerized networks that manage, analyze, and/or integratecomprehensive and cumulative animal health assessment data and geneticidentifier, genomic mapping, and genetic assessment data A comprehensiveapproach to animal health and genetic selection or management ofanimals, and their clinical care is the subject of the presentinvention.

Current laboratory and research systems and computerization have notachieved this, and nor have communication protocols been usedeffectively in this technological area to facilitate such a relationshipor relational bioinformatics database system for management anddissemination of this comprehensive and cumulative information.

More specifically, it is necessary in animal health diagnosis and carethat appropriate predictive testing for diseases and disorders ofanimals be achieved in order to reduce morbidity and mortality, andimprove the quality of life and lifespan. Currently this is not done inrelation to the health assessmant data of an animal together with thegenetic data related to that same animal. Current tests do not provideas much data as possible to attain correct diagnosis and disorderpredictions with the net result of an improvement in the quality of lifeand increased longevity. Moreso, currently available testing isunnecessarily complex and expensive in relation to the ability to be anaccurate predictor of diseases and disorders in animals, and hence theirlikely longevity.

SUMMARY OF THE INVENTION

The invention is directed to a method, apparatus and system ofobtaining, analyzing and reporting laboratory test data in relation tothe health assessmant data of an animal together with the genetic datarelated to that same animal.

These data include a panel of tests related to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokine and allergy testing, and markers of neoplasticand paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal.

According to one aspect of the invention, health profiling of an animalis effected to determine characteristics related to the temperament ofthe animal which impacts on its longevity. Biological laboratory testdata from a bodily fluid or tissue of an animal are analyzed. Such testdata relate to the level of neurotransmitter activity of the animal. Thedata relate to at least one of the value of serotonin, thegamma-aminobutyric acid (GABA), the dopamine, the norepinephrine, thehistamine, or the other neuropeptides of the animal. The value shouldfall within predetermined levels as a predictive determinant of theanimal's temperament (passivity, assertiveness, or aggressivity).

One other aspect of the invention relates health profiling of an animalto determine characteristics related to at least one of the immunestimulation reaction, evidence of neoplastic or paraneoplastic change,or the cellular inflammatory response of the animal. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

According to another aspect of the invention, health profiling of ananimal determines characteristics related to inherited organ dysfunctionor dysplasia of the animal, at least one of which is neuronal,neuromuscular or renal. Biological laboratory test data from a bodilyfluid or tissue of an animal are analyzed. The test data relate to anamino acid, carbohydrate, lipid or other metabolic component, body fluidor tissue marker of the animal. The data includes obtaining data relatedto at least one of the value of the methyl malonic acid, thefucose-containing cell metabolites, uric acid, normoglycemic glycosuria,amino acid uria, mannosidase containing cell metabolites, amyloiddeposition in tissues, neuronal ceroid lipofuscin deposition, anddeposition of gangliosides and other lysomal storage substrates of theanimal. The value should fall within predetermined levels as adeterminant of the inherited organ dysfunction or dysplasia.

According to a further aspect of the invention, health profiling of ananimal determines characteristics related to autoimmune thyroiditis ofthe animal. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to a physiologicor genetic marker for automimmune thyroiditis of the animal. The datarelates to at least one of the results of a comprehensive thyroidautoantibody test profile, DNA fingerprint (the gene map), and markersfor immunoglobulin receptors on B-cells, T-cell receptors, and proteinproducts of the major histocompatibility complex (AMC) genes (Class Iand II allellic HLA, DLA or equivalent antigenic specificities) of theanimal. Example assays to screen for MHC genes include restrictionfragment length polymorphism (RFLP), polymerase chain reaction (PCR)RFLP, PCR sequence-specific oligonucleotides (SSO) and PCRsequence-specific primers (SSP). The values should fall withinpredetermined levels as a determinant of autoimmune thyroiditis.

According to a further aspect of the invention, health profiling of ananimal determines characteristics related to presence of orsusceptibilty to mammary cancer of the animal. Biological laboratorytest data from a bodily fluid or tissue of an animal are analyzed. Thetest data relate to estrogen (estradiol-17β), estrogen receptors,interleukin (IL) 6, progesterone, and progesterone receptors. The valueshould fall within predetermined levels as a determinant of presence orsusceptibility to mammary cancer.

According to a further aspect of the invention, health profiling of ananimal determines characteristics related to the tissue environment ofthe eye and brain (ocular and blood-brain barrier) which are sitesprotected from the normal immunologic surveillance mechanisms.Biological laboratory test data from a bodily fluid or tissue of ananimal are analyzed. The test data relate to the soluble and cellularimmune inflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphycyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

According to a further aspect of the invention, health profiling of ananimal determines characteristics related to the tendency to bleedexcessively are determined. Biological laboratory test data from abodily fluid or tissue of an animal are analyzed. The test data relateto a comprehensive assessment of the hemostatic and coagulationfunction. The value should fall within predetermined levels as adeterminant of the presence of bleeding disorder.

The invention includes obtaining genetic data related to the animal, andrelating the generic data related to that animal with the biologicaldata. Also the profiling includes obtaining data related to the currenthealth condition of the animal.

More particularly the invention comprises combining genetic data ofanimals with health assessment data of animals thereby to permit ananalysis predicting health, disease and disorder probabilities andlongevity of selected animals the combination is analyzed, and a reportis provided to a remote user based on the analysis the health assessmentdata of the animal and the genetic data

In light of the above, there is provided by this invention a system formanaging animal diagnosis, including the performance of specific tests.The phenotypic and genotypic data and information relating to animals,particularly purebred animals can be used to enhance the prediction ofdisease and/or disorder.

The invention also provides a bioinformatics system for inputting,controlling, analyzing and outputting of a broad range of criteriarelated to the health, genetic background and longevity of animals. Thisincludes a system concerning phenotype data and genetic data relating toanimals. Further, there is provided a system for screening of geneticdata and genomic mapping, and integrating the phenotype healthassessment data and genetic identifier and assessment data in a CDPR.Moreover, there is provided a system for analyzing the health assessmentor phenotypic data with the interrelated genetic or genotypic data.Thereafter, those data and analyses are communicated from the CDPR in abroad range and in a manner that has not previously been possible.

The present invention offers a unique solution to above-describedproblems by providing an apparatus, method and system, in relation toanimals, for performing data analyses of biological specimens fromspecific subject animals or animal groups in relation to specificsubject animal or animal groups of genetic data. The apparatus, methodand system comprises a controller for obtaining, inputting, andanalyzing biological, physiological, and pathological test data togetherwith genomic mapping and genetic screening data into the CDPR.

The biological, physiological, and pathological data of the subjectanimal or animal group and the genetic data of the subject animal oranimal group are communicated to a remote user as raw data or asrelated, analyzed biological, physiological, and pathological data andgenetic data. The remote user can also appropriately access the CDPR toinput data to, or obtain data from, the CDPR.

The CDPR includes at least two databases, one of the databases containsgenetic information in relation to animals and the other is a phenotypicdatabase.

The genetic database is either a specific file of a selected animal or ageneralized animal database relating to group characteristics, and iscross-relatable with the phenotypic database of particular selectedsubject animals.

Additionally other databases can be used and cross-related to thesedatabases. The genetic database includes data from selected animals,animal families, animal breeds and/or data related to selected animaldiseases and/or disorders. Other databases include those related togenetic markers or maps of animals, databases related to epidemiology,purebred animal ownership, identification registries, and studbookregistries.

The phenotype, health profile, or health assessment database containsdata which is mostly phenotypic. The genotype database includes datawhich is in the category of mostly genotype or genetic and which mayinclude a second category of some phenotype data which predicts ormanifests the genotype and genetic data. The invention includes relatingthe phenotypic data to either one or both types of the genotypic data.

Information in the databases are used to build computer drivenstatistical models to predict the occurrence of specific diseases andlongevity for individual animals on a breed-by-breed or family and groupbasis. Multivariate statistical techniques are used including multipleregression, logistic regression, and Cox proportional hazards. As newdiagnostic technology and genomic information become available, thedatabase is continually expanded and the statistical models are updatedto enhance predictive ability. This ability to predict the occurrence ofdisease or disorder is used to develop and evaluate screening programsin veterinary medicine in order to detect disease earlier, therebyimproving the outcome and quality of life for animals and their owners.The information is also used to design disease prevention programs basedon dietary/environmental modification and selective breeding. Thedatabase is also used to explore previously unsuspected relationshipsbetween specific diseases such as cancer and diet, vaccination, orchemical exposures. There

There is provided means for inputting data into the genetic database andphenotypic database, and other databases, storing the data in thesedatabases, analyzing the data in a relational sense from the differentdatabases, and retrieving the data from these databases, namely thedatabases which are part of the CDPR.

A further aspect of the invention is the accessibility of the healthassessment database and/or genetic database or other databases of theCDPR by the remote user selected on the basis of password, securitycontrol, and financial payment such that the data can be transmittedinto and from the CDPR by a computer network. Use of selected passwords,encryption systems, and payment systems are employed to facilitate andrestrict the flow of data in and/or out of the databases. Alerts can beset up to advise of attempts at unauthorized access to the CDPR. Thecomputer network may conveniently include the Internet.

As required, the data in the CDPR can also be distributed to multipleauthorized remote parties, namely third parties for research or otheranalysis. The invention also includes a method and system for achievingthis.

Further aspects of the present invention will become apparent in thecourse of the following description and by reference to the attacheddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an overall view of a web-based system to provide access to adatabase management system of an animal genetic database and a healthassessment database of the invention, in relation to the Internet.

FIG. 2 is a graphical illustration of a computer network, namely theInternet.

FIG. 3 is a block diagram of an exemplary computer system for practicingvarious aspects of the invention.

FIG. 4 is a view of a browser for the database management system foraccessing an animal genetic database and a health assessment database ofthe invention.

FIG. 5 is a basic flow diagram illustrating an exemplary process bywhich an operator of a CDPR receives and transmits data relating tohealth assessment and genetic information.

FIG. 6 is a detailed flow diagram of the system steps employed in oneembodiment of the present invention wherein a remote user accesses andoutputs data.

FIG. 7 is a detailed flow diagram of the methods and steps employed by aremote user to add data to the database.

FIG. 8 is a flow chart illustrating an exemplary process by which thelaboratory dynamically contributes, transmits and receives dataassociated with health assessment and genetic data to the CDPR.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention will now be described in detail with reference toa few preferred embodiments thereof, as illustrated in the accompanyingdrawings. In the following description, numerous specific details areset forth in order to provide a thorough understanding of the presentinvention. It will be apparent, however, to one skilled in the art, thatthe present invention may be practiced without some or all of thesespecific details. In other instances, well known process steps have notbeen described in detail in order to not unnecessarily obscure thepresent invention.

Genetic Screening and Counseling of Purebred Animals

The common practice to line-breed and inbreed purebred animalsfacilitates the transmission and recognition of congenital and heritabledefects. Large-scale screening programs for the identification ofgenetically affected and carrier animals are an effective way todiscover and eventually control the frequency of these defects withinthe population at large. Screening programs of this type have been usedsuccessfully in humans for many years (e.g. Tay-Sachs disease,phenylketonuria) and more recently have been applied to animals (e.g.mannosidosis in cattle; hip dysplasia, eye, blood and heart diseases indogs). Genetic screening may be essential to the survival of breeds inwhich mild or moderately severe defects have been propagated unknowinglyfor many generations.

It is important that the top-producing sires and foundation dams of abreed be screened for conditions prevalent in that breed or in thespecies generally, because they represent the major nucleus of geneticmaterial for the current and future decades. Most purebred animalsraised today have evolved over the years from a relatively small genepool. Even though a particular genetic disorder may initially have beenrecognized in a specific line or family within a breed, all importantbreeding stock of the breed need to be screened because their similargenotype evolved from the original restricted gene pool. If thisapproach is not taken, the frequency of genetic defects in the breedwill inevitably increase and have a negative impact on overall healthand longevity.

Depending on the mode of inheritance, different approaches may need tobe applied for the detection and control of genetic disorders. It isadvantageous to be able to select against heterozygotes (carriers)rather than have to eliminate affected individuals from a breedingprogram once the condition is manifested. Control and elimination of thedisease by testing are feasible and reliable in cases where theasymptomatic or carrier state has an expressed phenotypic, biochemicalmarker (e.g., as measured in a blood, urine or saliva test,electrocardiogram, skin biopsy, eye examination, or hair analysis). Somecurrent examples include testing for bleeding disorders like vonWillebrand disease and hemophilia; autoimmune thyroid disease leading tohypothyroidism; the various eye, heart, metabolic enzyme and storagedisorders; and the bone and neuromuscular diseases. Coupled with thisapproach to eliminating undesirable traits is the necessity to evaluatebreeding stock regularly for overall soundness, reproductive health andperformance, and longevity.

Features Related to Genetic and Other Data Associated with Animals

A. Physical Characteristics of Disease

In the early days when animal breeders began recognizing recurringsymptoms of disease states or physical characteristics, the undesirablefeatures of these traits led them to select away from the problems bytest mating and eliminating affected animals from the breeding pool.While this remains one way to select against inherited and congenitaldiseases, more reliable approaches have been implemented by screeningfor biochemical markers and most recently by using molecular genetictechniques.

A comprehensive worldwide database contains the following informationfor individual purebred animals:

Host characteristics: age, sex, neuter status, pedigree, height, weight,body mass index, coloration and markings, eye color, etc.

Diet: type and amount of dog and human foods consumed, vitamin andmineral supplements, frequency of feeding. This is used to derive thepercentage of calories derived from fat, carbohydrate, and protein.

Medical history: occurrence of diseases, infections, etc., includingdate of onset, treatment, duration, and outcome, cause of death andmethod of diagnosis; type and amount of medications used for treatmentor prevention of disease; type and frequency of vaccinations.

Personality and temperament: based on previously used personalityscales.

Laboratory data: consists of routinely collected blood, serum chemistrytests, urinalysis, etc., as well as laboratory tests performed to screenfor or diagnose specific conditions such as immune-mediated thyroiditis,hypothyroidism, cancer, etc.

Special diagnostic test results: include tests for hip dysplasia,congenital eye diseases, congenital heart diseases, blood disorders, andother suspected inherited disorders as tests become available.

Genetic information: derived from the canine genome project as well astests for specific inherited conditions such as progressive retinalatrophy, hemophilia, and von Willebrand disease.

B. Phenotypic Markers of Disease

While animal breeders (e.g., of purebred dogs) for the most part haveendorsed the long standing genetic screening programs for hip dysplasiaand blood and eye diseases, emphasis on other genetic disorders hasarisen, now that the major infectious, parasitic, nutritional andtraumatic diseases have been addressed and controlled to a large extentby modem veterinary medical practice. Furthermore, most animal fanciersbecome involved in breeding and showing their animals as a hobby ratherthan a prosperous enterprise as might apply to livestock or theperformance racing industry. The intense commitment to this hobby withits attendant social praise for the successful breeder and exhibitor,poses ethical dilemmas when prize-winning animals are identified ascarriers of a particular genetic disorder.

For about three decades, veterinary and comparative geneticists havedeveloped and relied upon physical and biochemical markers of specificgenetic traits to identify carrier and affected animals. These methodsaimed to produce reliable, practical, and affordable tests that would bepredictive of the gene product, and therefore the genotype of aparticular genetic disorder. To be considered accurate and predictive,retrospective analyses of data developed from these testing programswere compared to the pedigrees of animals being screened as a means ofvalidating the tests. Such genetic screening tests would be consideredreliable if they correctly identified animals as having the normal andabnormal genotypes at least 80% of the time.

An important indicator of overall health of an individual animal orbreed is longevity. Relationships between a specific health-relatedcondition and an animal's genetic, environmental influences and lifespanhave been characterized, in part, for several important diseases of dogsincluding bone cancer (osteosarcoma) and gastric dilatation-volvulus(GDV).

Osteosarcoma: The risk of osteosarcoma increases with increasing age,increasing weight and increasing height. Compared with the Germanshepherd breed, the highest risk of osteosarcoma occurs among large andgiant breeds, while small breeds have reduced risk. Furthermore, therisk of osteosarcoma is increased two-fold in neutered dogs.

GDV: Factors that increase the risk of GDV in purebred dogs are malegender, being underweight, eating only one meal per day, eating rapidly,and a fearful temperament. Factors that decrease the risk of GDV includea happy temperament and inclusion of table foods in the diet. Thelifetime risk of developing GDV in large and giant breed dogs is 20% and23%, respectively, whereas the lifetime risk of dying of GDV for thesebreeds is 6%.

Similarly, the comparative longevity of different dog breeds has beendescribed using the age of death and other descriptive characteristicsof more than 38,000 dogs that were included in a large veterinarydatabase. Predictable relationships were found between the breed andsize of dogs and the average age of death. It was noted that dogs areunique among animal species in having a more than 50-fold difference inadult body size and a corresponding large difference in longevitybetween the smallest and biggest dog breeds. Since these dog breeds havemore than 99% of their genome in common, it suggests that the geneticcode for both size and longevity is contained within a very small partof the dog's genome. As mapping of the canine genome progresses, itshould be possible to identify not only genes that code for specificdiseases such as cancer and GDV, but also for the genes that determinebody size and longevity.

C. Genotypic Markers of Disease

Recent advances in molecular genetics have focused on mapping the humangenome, and this has stimulated interest in developing parallel geneticmaps for animals. For example, it is estimated that a minimum of tenyears and several million dollars will be needed to map the caninegenome. Once developed, a genetic map provides information about therelative order and placement of genes or specific DNA markers onspecific chromosomes. This allows one to locate specific regions onchromosomes where genes of interest are likely to be found. Once amolecular marker is identified close to a specific gene of interest,screening tests for this particular marker can be used to identifyindividuals carrying or expressing the trait.

Other information in relation to genetic screening and health assessmentis contained in the literature references listed at the end of thespecification. The contents of these materials are incorporated byreference herein.

Some of the characteristics of animals with which this invention isconcerned are the following:

Genotype & Some Animal Mostly Mostly Phenotype (Gene CharacteristicsPhenotype Genotype Product) Species X Purebred X Crossbred X Mixed breedX Size X Weight X Age X Sex X Lifespan X Body type X Color X Familyhistory X DNA testing X Genomic mapping X Bloodtype X Thyroid function Xvon Willebrand factor X Hemophilia X Other bleeding disorders X GlucoseX Cholesterol X Alkaline phosphatase X Alanine aminotransferase X Bileacids X Cortisol X Cataracts X Progressive retinal atrophy XMicroophthahnia X Dry eye (KCS) X Hip dysplasia X Arthritis XTemperament X Ruptured cruciate ligament X Hemolytic anemia X UrinalysisX Kidney stones X Bloat (gastric dilatation) X Pyoderma X Seborrhea XSebaceous adenitis X Umbilical hernia X Inguinal hemia X Epilepsy XHeartworm disease X Cardiomyopathy X Patent ductus arteriosus XImmunoglobulin levels X

In the category of genotype and some phenotype, the phenotype component(measurable gene product) is typically less than 20%.

Diagnostic Testing

The development of one or more assays or techniques for performing theinvented testing protocols, standards and procedures of the presentinvention is straightforward, and within the knowledge of a personskilled in the art. The contents of U.S. Pat. No. 5,830,7009 (Benson)entitled “Detection Method for Homologous Portions of a Class ofSubstances” is indicative of some of the tests and formats that arepossible. The contents of that patent are incorporated by referenceherein.

One or more of a panel of tests relate to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, inborn errors of metabolism, paternity, DNAfingerprinting, hemostasis and coagulation function, vaccinal antibodystatus, adverse and potential adverse vaccine reaction, infectiousdiseases, pathology, blood typing and bone marrow analysis, cellcytotoxicity, cytokines and allergy testing, and markers of neoplasticor paraneoplastic change. These data are relevant to the likelymorbidity, likely longevity, and/or the potential risk for disease ordisorder for the animal.

The following are some examples of diseases, disorders, and physiologicstates that use one or more of the diagnostic test panels set out below:

EXAMPLES Example 1 Temperament and Longevity

Characteristics related to the temperament of the animal which impactson its longevity are determined. Biological laboratory test data from abodily fluid or tissue of an animal are analyzed. Such test data relateto the level of neurotransmitter activity of the animal. The data relateto at least one of the value of serotonin, the gamma-aminobutyric acid(GABA), the glutamate, the dopamine, the glycine, the aspartate, theacetylcholine, the norepinephrine, the histamine, the substance P, thevasopressin, the vasoactive intestinal peptide, the neurotensin, or theother neuropeptides of the animal. The value should fall withinpredetermined levels as a predictive determinant of the animal'stemperament (passivity, assertiveness, or aggressivity).

Methods for measuring neurotransmitters are well known in the art.Neurotransmitters such as serotonin, epinephrine, norepinephrine,glutamate, and GABA can be measured by standard immunochemicaltechniques involving commercially available antibodies, eitherpolyclonal or monoclonal. Such antibodies are commercially availablefrom sources such as Sigma Chemical Company (St. Louis, Mo.). Theseimmunochemical techniques can involve either radioimmunoassay or otherwell-established assay techniques, such as ELISA (enzyme-linkedimmunosorbent assay). These neurotransmitters can also be measured bystandard non-immunochemical techniques such as gas chromatography.Neuropeptide neurotransmitters are preferably measured by immunochemicaltechniques.

Test panels Nos. 1, 2, 3, 8 and 10 set out below can be used to obtaindata for this Example 1.

Example 2 Immune Stimulation and Cellular Inflammatory Response

Characteristics related to at least one of the immune stimulationreaction, evidence of neoplastic or paraneoplastic change, or thecellular inflammatory response of the animal are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relates to at least one of cell cytotoxicitymarkers, cytokine and chemokine levels, immunoglobulin levels, type andamount of lymphocyte subsets and lymphocyte markers, and markers ofneoplastic or paraneoplastic change of the animal. The value should fallwithin predetermined levels as a determinant of the immune stimulationreaction, neoplastic or paraneoplastic change, or the cellularinflammatory response.

Methods for measuring lymphokines and other cytokines are well known inthe art. These compounds are typically measured by immunochemicaltechniques using commercially available monoclonal antibodies or othermethods.

Test panels Nos. 1, 3, 4, 8, 9 and 10 set out below can be used toobtain data for this Example 2.

Example 3 Inherited Organ Dysfunction or Dysplasia

Characteristics related to inherited organ dysfunction or dysplasia ofthe animal, at least one of which is neuronal, neuromuscular or renalare determined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to an amino acid,carbohydrate, lipid or other metabolic component, body fluid or tissuemarker of the animal. The data includes obtaining data related to atleast one of the value of the methyl malonic acid, the fucose-containingcell metabolites, blood or urine urate or uric acid metabolites,normoglycemic glycosuria, mannosidase containing cell metabolites, aminoacid uria, amyloid deposition in tissues, neuronal ceroid lipofuscindeposition, and deposition of gangliosides and other lysomal storagesubstrates of the animal. The value should fall within predeterminedlevels as a determinant of the inherited organ dysfunction or dysplasia.

Test panels Nos. 1, 3, 5, 9 and 10 set out below can be used to obtaindata for this Example 3.

Example 4 Autoimmune Thyroiditis

Characteristics related to autoimmune thyroiditis of the animal aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to a geneticmarker for automimmune thyroiditis of the animal. The data relates to atleast one of the results of a comprehensive thyroid antibody testprofile, DNA fingerprint (the gene map), and markers for immunoglobulinreceptors on B-cells, T-cell receptors, and protein products of themajor histocompatibility complex (MHC) genes (Class I and II allellicHLA, DLA or equivalent antigenic specificities of the animal. Testassays to screen for MHC genes include restriction fragment lengthpolymorphism (RFLP), polymerase chain reaction (PCR) RFLP, PCRsequence-specific oligonucleotides (SSO) and PCR sequence-specificprimers (SSP). The value(s) should fall within predetermined levels as adeterminant of autoimmune thyroiditis.

Test panels Nos. 1, 2, 3 and 10 set out below can be used to obtain datafor this Example 4.

Example 5 Mammary Cancer

Characteristics related to presence of or susceptibility to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of the presence of orsusceptibility to mammary cancer.

Test panels Nos. 1, 2, 3 and 10 set out below can be used to obtain datafor this Example 5.

Example 6 Immune Surveillance

Characteristics related to the tissue environment of the eye and brain(ocular and blood-brain barrier) which are sites protected from thenormal immunologic surveillance mechanisms are determined. Biologicallaboratory test data from a bodily fluid or tissue of an animal areanalyzed. The test data relate to the soluble and cellular immuneinflammatory response mediators (cytokine and chemokine levels,immunoglobulin levels, and lymphycyte susbset markers). The value shouldfall within predetermined levels as a determinant of integrity ofprotected immune surveillance mechanisms.

Test panels Nos. 1, 3, 5, 6, 8, 9 and 10 set out below can be used toobtain data for this Example 6.

Example 7 Inherited Bleeding Disorders

Characteristics related to the tendency to bleed excessively aredetermined. Biological laboratory test data from a bodily fluid ortissue of an animal are analyzed. The test data relate to acomprehensive assessment of the hemostatic and coagulation function. Thevalue should fall within predetermined levels as a determinant of thepresence of bleeding disorder.

Test panels Nos. 1, 7, and 9 set out below can be used to obtain datafor this Example 7.

Test Panels

The following are some specific diagnostic test panels and specializeddiagnostic tests and test groups used to monitor health, morbidity,mortality and longevity of animals and animal families, and to predictthe potential risks of disease or disorder:

Test 1: Comprehensive Diagnostic Test Panel

Patient phenotypic descriptors and genotypic descriptors/background;complete blood count (CBC) and platelet count, platelet size, plateletmorphology; serum chemistry profile [e.g., AST (SGOT), ALT (SGOT),bilirubin (total, direct and indirect), alkaline phosphatase, GGT(GGTP), total protein, albumin, globulin, A/G ratio, cholesterol, BUN,creatinine, BUN/creatinine ratio, phosphorus, calcium, correctedcalcium, calcium/phosphorus ratio, glucose, amylase, lipase, sodium,potassium, Na/K ratio, chloride, CPK, triglyceride, osmolality];complete thyroid profile (total T4, total T3, free T4 (ED or other),free T3, T3 autoantibody, T4 autoantibody, TSH, thyroglobulinautoantibody); and urinalysis, urine culture, and sensitivity, ifindicated.

Test 2: Diagnostic Test Panels for Endocrine Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

1) Thyroid Function: total T4, total T3, free T4 (ED or other), free T3,T3 autoantibody, T4 autoantibody. Molecular screening for autoimmunethyroiditis including immunoglobulin receptors on B-cells, T-cellreceptors, and major histocompatibilty complex (MHC) genes Class I andII allellic HLA, DLA, or equivalent animal antigenic specificities(RFLP, PCR/SSO, PCR/SSP).

2) Adrenal Function: cortisol (asal and after stimulation with ACTH, orserially after suppression with high or low-dose dexamethazone);endogenous cortisol; and endogenous ACTH.

3) Reproductive Function: testosterone; estradiol-17β; relaxin(pregnancy diagnosis); progesterone; luteinizing hormone; estronesulfate; follicle stimulating hormone; vaginal cytology and/or culture;testicular cytology or biopsy; prostatic cytology, biopsy or wash;screens for ovarian or testicular remnants.

4) Pancreatic Function: amylase; lipase; glucose; glucagon, trypsin-likeimmunoreactivity (TLI); insulin, fructosamine; glycosylated hemoglobin.

5) Parathyroid Hormone Function: parathormone; ionized calcium.

6) Other Endocrine Function: aldosterone; 21 adrenal hydroxylase;vanylla mandelic acid (VMA, for epineplrine and norepinephrinemetabolities).

Test 3: Diagnostic Test Panels for Immunologic Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all of selected tests from the following list:

Antinuclear antibody (ANA)—if positive, run double stranded, singlestranded, speckled, anti-RNA levels; Coombs' testing (direct andindirect; elution or microbeads gel-test); rheumatoid factor, serumelectrophoresis—if abnormal, run immunoelectrophoresis, isoelectricfocusing, immunoblotting (Western, Northern, Southern blots);immunoglobulin levels (IgG, IgA, IgM, IgD and IgE); complement levels(C1, C1a, C1 esterase inhibitor, C3, C4, C5-C9); LE-prep testing; lupusanticoagulant (dilute Russell's viper venom test or dilutional inhibitortest); urine protein SDS-gel electrophoresis; fibronectin andanti-fibronectin antibody; flow cytometry with fluorescence activatedcell sorter (FACS, for leukocyte subsets and markers such as CD4⁺ andCD8⁺; leukocyte chemotaxis (leukocyte migration inhibition test,leukotrienes); cytokines including lymphokines and monokines(macrophage-derived) such as the interleukins (IL) [e.g. IL-6 regulatedby estradiol-17β, IL-8 acts as neutrophil chemotactic factor],interferons, tumor necrosis factor(s), leukotrienes, colony stimulatingfacors, transforming growth factor-beta and chemokines (inflammatorycytokines); anti-platelet antibody tests (serum, bone marrow);anti-megakaryocyte antibody tests (IFA, elution); and anti-leukocyteantibody tests (direct and indirect anti-neutrophil cytoplasmicantibody, antilymphocyte antibody, etc.).

Test 4: Diagnostic Test Panels for Gastrointestinal Function andNutritional Analysis

Patient phenotypic descriptors and genotypic descriptors/background,plus nutritional and food supplement past and current use, plus any orall of selected tests from the following list:

Serum nutrients and vitamin analysis; CBC as in Test 1; serum chemistryas in Test 1 plus magnesium and iron; urinalysis, urine culture andsensitivity, if indicated; urine fractional excretion; serum and urineamino acid analyses; serum cobalamin (vitamin B₁₂) and folate analysis;TLI [same as Test 2, 4)]; fecal flotation; Giardia screen, Clostridiumperfringens enterotoxin test; cryptosporidiosis test (FA); toxoplasmosistest; bile acids test (resting and postprandial); fecal alpha-₁ proteaseinhibitor activity. If any abnormalities are present, furtherinvestigation includes ion-coupled plasma emission spectroscopy (ICP)for mineral analysis, and electrophoresis.

Test 5: Diagnostic Test Panels for Inborn Errors of Metabolism

Characteristics related to presence of or susceptibility to mammarycancer of the animal are determined. Biological laboratory test datafrom a bodily fluid or tissue of an animal are analyzed. The test datarelate to estrogen (estradiol-17β), estrogen receptors, interleukin (IL)6, progesterone, and progesterone receptors. The value should fallwithin predetermined levels as a determinant of presence orsusceptibility to mammary cancer.

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Genetic screening tests including blood and urine analyses formucopolysaccharides, cerebrosides, glycogen-storage diseases,phenylketones, phosphofructolinase, mannosidases, combined and specificimmunoglobulin deficiencies/dysfunctions; skin and tissue biopsies;karyotyping for genotype determination; and DNA marker analyses.

Test 6: Diagnostic Test Panels for Paternity Testing and DNAFingerprinting

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Major histocompatibility complex (MHC) Class I and II alleles [analysesof HLA, DLA, or equivalent animal antigenic specificities]; genotyping;gene mapping and fingerprinting.

Test 7: Diagnostic Test Panels for Hemostatic and Coagulation Function

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

Platelet count, platelet size (blood slide, mean platelet volume),platelet morphology (light, scanning, and electron microscopy);prothrombin time; partial thromboplastin time; fibrinogen;fibrin-fibrinogen degradation products (D-dimer test); platelet functiontests (aggregation, release, clot retraction, whole blood aggregation,ristocetin cofactor); von Willebrand factor antigen and multimeranalysis; specific coagulation factor analyses (factors II, V, VII,VII:C, IX, X, XI, XII, XIII); fibrinolytic tests (plasminogen, plasmin,antiplasmin, tissue plasminogen activator, dilute whole blood lysistest, euglobulin lysis test); anti-thrombin III test; circulatinganticoagulant tests; platelet factors 3 and 4 (heparin cofactor);protein C; protein S; kinin-kinogen tests; prekallikrein test;alpha₁-antitrypsin assay; alpha₂-macroglobulin assay; C₁ esteraseinactivator assay; anti-platelet antibody, and anti-megakaryocyteantibody tests (see Test 3).

Test 8: Diagnostic Test Panels for Vaccinal Antibody Status, and AdverseVaccine or Potential Adverse Vaccine Reaction

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

1) Serology for Vaccinal Antibody: canine distemper, canine parvovirus,canine coronavirus, canine parainfluenza virus, infectious caninehepatitis virus, canine bordetella, canine Lyme (borrelia), canineleptospirosis, rabies virus, feline panleukopenia virus, feline leukemiavirus, feline infectious peritonitis virus, feline immunodeficiencyvirus, feline calicivirus, feline hexpesvirus, and equine herpes virusesI-IV), etc.

2) Adverse Vaccine Reactibn: Same as Test 3, but especially CBC; ANA;Coombs' test; platelet count, size, and morphology; anti-neutrophilcytoplasmic antibody, marker for vasculitis; complement tests; leukocytechemotaxis tests; urine protein/creatinine ratio; anti-plateletantibody; immunoglobulin levels, especially IgG, IgA, IgM; flowcytometry (FACS) leukocyte subsets; cell cytotoxicity analysis;cytokines, especially chemokines; and complete thyroid autoantibodypanel.

3) Potential (High Risk) Vaccine Reaction: especially for breeds such asthe Akita, Weimaraner, Standard poodle, Eskimo Dog, harlequin GreatDane; CBC; ANA; platelet count, size and morphology; complete thyroidautoantibody panel; cell cytotoxicity analysis; cytokines; andimmunoglobulin levels, especially IgG, IgA, IgM;

Test 9: Diagnostic Test Panels for Infectious Diseases

Patient phenotypic descriptors and genotypic descriptors/background,plus any or all selected tests from the following list:

1) North America: Ehrlichia species (E. canis, E. risticii, E. equi, E.platys, etc.); Rickettsia rickettsei (RMSF); Borrelia species (Lymedisease); Bartonella species (B. henselae, B. vinsonii, B. clarridgeiae,B. kochlerae); systemic fungal diseases (Coccidioides spp, Cryptococcusspp, Histoplasma spp, Blastomyces spp, Aspergillus spp, ringworm); mangemites (Demodex, Sarcoptes, Chyletiella, etc.); enteric diseases(Clostridium perfringens enterotoxin);protozoan diseases (Toxoplasmaspp.; Coccidia spp; Giardia spp); retrovirses (feline leukemia virus,feline immunodeficiency virus, equine infectious anemia virus, bovineleukemia virus, caprine arthritis virus; Corona viruses (caninecoronavirus, feline enteric coronavirus, feline infectious peritonitisvirus; Babesia spp (B. canis, B. gibsoni); Dirofilaria spp (heartworm);other parasitic diseases (fleas, ticks, roundworms, tapeworms,hookworms, Strongyles and other intestinal parasites); and Chlamydiaantigen (PCR testing).

2) International: Same as above plus Leishimania spp; Trypanosoma spp.;Anaplasma spp; Yersina pestis.

Test 10: Other Diagnostic Tests

Patient phenotypic descriptors and genotypic descxiptors/background,plus any or all selected tests from the following list:

Pathology (anatomic, histological, cytologic, immunohistochemical,electromicroscopy, FACS); blood typing; bone marrow analysis andspecific immunohistochemical staining; RFLP and PCR testing (applicableto many of the above categories); IFA and FA testing; ELISA testing,cell cytotoxicity testing, cytokine testing (see Test 3, other cytotoxiccell and mitochondrial tests); markers of neoplastic and paraneoplasticchange (cancer); neurotransmitters including serotonin, thegamma-aminobutyric acid (GABA), the glutamate, the dopamine, theglycine, the aspartate, the acetylcholine, the norepinephrine, thehistamine, the substance P, the vasopressin, the vasoactive intestinalpeptide, the neurotensin, or the other neuropeptides; and amino acidprofiling.

Overall System

FIG. 1 is an overview of the web-based system to provide access to theinvented database management system. With this system multiple users,for instance, remote users 8, access the web site 4 using the Internet6. Each of the users 8 has a computer terminal with the appropriatesoftware for accessing Internet. The users 8 may be unknown to the webserver computers 10 and 12. Each user 8 is allowed to browse the website and explore how the system functions.

There are several aspects to maintain security of information maintainedin the database server 22 and a banking system 28. A fireall 20 preventsany user 8 from accessing any of the components behind the firewall 20.In this way the users 8 have access to the web server computers 10 and12, but only have access to the database server 22 through the firewall20. The database server 22 maintains, among other things, variousdatabase fields with respect to each of the health profiles of subjectsand the genetic information of a subject and groups. The database 22maintains the services with a designation associated to determine whathealth assessment data and genetic data can be browsed by the users 8.Each of the web server computers 10 and 12 allow users 8 to view subjectand group categories and actual services and data products which areavailable from the database.

The web server computers 10 and 12 can be identical and can beduplicated as additional load or growth on the system occurs. The webserver computers 10 and 12 share the responsibility for servicing theusers of the site. This arrangement provides for expandability of thesystem by merely adding additional web server computers as necessary.

Preferably, the system includes an appropriate computer terminal 24 forinterfacing with independent financial institutions which are connectedon-line via the serial connection 26 to the financial institutioncomputers 28. This allows automatic real time confirmation of the accessof health profile and genetic data services and products. Once a userrequires access to a product or service, the user goes through anidentification or registration process and the exchange of financialinformation to allow for credit or debit card payment of the purchase.This is verified, confirmed and authorized by the appropriate banksystem institution 28. Confirmation of the purchase or deposit of data,or a service is made by a mail server 34 which sends an E-mail to theuser 8 confirming the purchase or deposit. The mail server 34 allows formail to be received and sent out. Security of the various databases ismaintained. Alert messages are generated when an unauthorized access isattempted. Verification messages, authorization messages andconfirmation messages are generated as appropriate.

The database server 22 is also designed to interact with an inputcomputer 32 operated by a CDPR. A firewall 30 serves to preventunauthorized access to the database server 22 or to the input computer32. The input computer 32 can input health profile data and genetic datato the database, after appropriate access and/or passwords are enteredinto the system. Similarly, users 8 through their own computers can useappropriate access codes and passwords to access input data to thedatabase server 22. This is tightly controlled for security reasons. Thedata may only be added to an independent sub-database of the data server22, and only after scrutiny by the CDPR operator of the database throughinput computer 32, will this data from users 8 be subsequently added tothe main database server 22.

FIG. 2 is an illustration of the Internet and its use in the system ofthe invention. The Internet 6 is a network of millions of interconnectedcomputers 40 including systems owned by Internet providers 42 andinformation systems 44 such as America Online™. Individual or corporateusers may establish connections to the Internet in several ways. A useron a home PC 46 may purchase an account through the Internet provider42. Using a modem 48, the PC user can dial up the Internet provider toconnect to a high speed modem 50 which, in turn, provides a full serviceconnection to the Internet. A user 52 may also make a somewhat limitedconnection to the Internet through a system 20 that provides an Internetgateway connection 54 and 56 to its customers. The database 22 is alsoconnected into the Internet 6 through an appropriate modem or high speedor direct interface 58. The database 22 is operable and maintained bythe CDPR operator computer 60. Users of the databases of the inventionwould access the Internet in an appropriately selected manner.

FIG. 3 is a block diagram of an exemplary computer system 100 forpracticing various aspects of the invention. The computer system 100includes a display screen or monitor 104, a printer 106, a disk drive108, a hard disk drive 110, a network interface 112, and a keyboard 114.The computer system 100 includes a microprocessor 116, a memory bus 118,random access memory (RAM) 129, read only memory (ROM) 122, a peripheralbus 124, and a keyboard controller 126. The computer system 100 can be apersonal computer, such as an Apple computer, e.g., an Apple Macintosh™,an IBM™ personal computer, or a compatible, a workstation computer, suchas a Sun Microsystems™ or Hewlett-Packard™ workstation, or some othertype of computer.

Microprocessor 116 is a general purpose digital processor which controlsthe operation of computer system 100. Microprocessor 116 can be asingle-chip processor or can be implemented with multiple components.Using instructions retrieve from memory, the microprocessor 116 controlsthe reception and manipulation of input data and the output and displayof data on output devices.

Memory bus 188 is used by the microprocessor 116 to access RAM 120 andROM 122. RAM 129 is used by microprocessor 116 as a general storage areaand as scratch-pad memory, and can also be used to store input data andprocessed data. ROM 122 can be used to store instructions or programcode followed by microprocessor 116 as well as other data.

Peripheral bus 124 is used to access the input, output, and storagedevices used by computer system 10. These devices include the displayscreen 104, printer device 106, disk drive 108, hard disk drive 110, andnetwork interface 112. The keyboard controller 126 is used to receiveinput from the keyboard 114 and send decoded symbols for each pressedkey to microprocessor 116 over bus 128.

The display screen or monitor 104 is an output device that displaysimages of data provided by microprocessor 116 via peripheral bus 124 orprovided by other components in computer system 100. The printer device106 when operating as a printer provides an image on a sheet of paper ora similar surface. Other output devices such as a plotter, typesetter,etc. can be used in place of, or in addition to the printer device 106.

The disk drive 108 and hard disk drive 110 can be used to store varioustypes of data. The disk drive 108 facilitates transporting such data toother computer systems, and hard disk drive 110 permits fast access tolarge amounts of stored data.

Microprocessor 116 together with an operating system operate to executecomputer code and produce and use data. The computer code and data mayreside on RAM 120, ROM 122, or hard disk drive 120. The computer codeand data could also reside on a removable program medium and loaded orinstalled onto computer system 100 when needed. Removable programmediums include, for example, CD-ROM, PC-CARD, floppy disk and magnetictape.

The network interface circuit 112 is used to send and receive data overa network connected to other computer systems. An interface card orsimilar device and appropriate software implemented by microprocessor116 can be used to connect computer system 100 to an existing networkand transfer data according to standard protocols. As such he computersystem is connectable through an interface device with the Internet 6.

Keyboard 114 is used by a user to input commands and other instructionsto computer system 100. Other types of user input devices can also beused in conjunction with the present invention. For example, pointingdevices such as a computer mouse, a track ball, a stylus, or a tabletcan be used to manipulate a pointer on a screen of a general-purposecomputer.

The present invention in relation to the animal database management ofdata can also be embodied as computer readable code on a computerreadable medium. The computer readable medium is any data storage devicethat can store data which can be thereafter read by a computer system.Examples of the computer readable medium include read-only memory,random-access memory, magnetic data storage devices such as diskettes,and optical data storage devices such as CD-ROMs. The computer readablemedium can also be distributed over network coupled computer systems sothat the computer readable code is stored and executed in a distributedfashion.

Specific System

FIG. 4 illustrates a browser system for use with the database system ofthe invention. A browser goes through a number of preliminary screensand logic steps, and reaches a screen 60 entitled “Next Entry”. Thisscreen provides data details or information generally indicated as 62.Clicking on any of these categories allows the user to review databasedetails 64, data specific details as generally indicated by 66. In thisway, the user can index through a number of screens to get informationregarding the different databases of the system. In addition, clickingon any of the triggers 70, 72, 74 and 76 is possible. These correspondto HOW IT WORKS, SECURITY, EXTENDED DATA and PRE-REGISTRATION. Clickingon trigger 70 provides the user with information on how the processworks, explains the system, and provides details on how the user canparticipate in the database and obtain data or input data. Clicking ontrigger 72 provides details regarding security of the system andautomatic payment. In some cases, products and services are offered withextended data and clicking on trigger 74 which can provide details ofthe extended data and explains that this may only be available oncertain services or products.

Trigger 76 allows a user to pre-register and obtain user ID number. ThisID number is combined with financial information retained in thedatabase in an encrypted form. The pre-registration trigger 76 followswith step 78 which is to gather personal information such as credit cardnumber and expiry date to allow for automatic payment. Step 80 is tovalidate a current existence in the database, if this occurs. With anegative answer, the user is directed into a registration processindicate as 82. A user ID is assigned and a password is entered. Thisinformation is maintained in a portion of the database 22. At 84 theuser is provided a screen identifying the user ID at screen 86. If theuser already exists, the registration process is rejected at 88 and theuser is advised of the information at the display 86. The screen at 86would also represent the information which is available in the database22.

In FIG. 5 there is shown a basic block diagram of the components makingup the CDPR. There is the phenotype database or physical health database200 and a genotype database or genetic information database 201. Theseare contained in part of the overall CDPR database 202. User input 203can be obtained from a remote user such as a veterinarian, owner,breeder, or the operator of the database, an agent or researcher. Theoutput from the database 204 could be to the veterinarian, owner,breeder, operator, agent or researcher.

FIG. 6 shows a relationship for retrieving data from the database 202.The user 8 is represented here as a veterinarian, owner, breeder,operator, or researcher 203 who accesses the CDPR 202 accesses a firstscreen through a computer network 6 which inquires about informationabout the user. An access request message is sent, and an appropriateaccess enabling message is transmitted. The user 203 can obtain partialor full access to the CDPR 202 according to the scale of authority givento the user 203 to access data. There is a computer program system 205to ensure that payment is made as appropriate before access to the CDPR202 is granted. In some situations, the appropriate access code 204 canpermit bypassing the payment requirement 205 as indicated by line 206.Payments 205 through the computer program can be effected by a creditcard entry and automatic transfer to a financial institution on behalfof the operator of the CDPR 202. Such payment for access to the databaseis effected by a system which is well known in the art. The financialinstitution will appropriately credit the operator of the CDPR 202 in afinancial manner as established between the operator and the financialinstitution.

Within the CDPR 201 there is the ability to access the physical healthphenotype database 200, the genotype database 201, and other databases207, 208 and 209, respectively. The phenotypic and genotypic informationtogether with other database information can be presented on a singlescreen or monitor or other viewing means, for instance, hard copyformat. The access therefore can be to multiple databases containedwithin the CDPR 202. After accessing the physical health database 200,the user obtains an analysis report from module 210. The user is thenable to read the analysis as indicated by 211 and output the analysisfrom the read-out 211 as indicated by output 212. The output 212 can bea computer screen read-out, fax or voice information.

The physical health or phenotype database 200 is subject or groupspecific. In other words, the data obtained in that database is specificto a particular animal or animal group (breed, family, species, etc.)which has been the subject of a laboratory or research biologicalexamination such that fluid or tissue samples have been subject toanalysis in one or more laboratory or research environments. Thesebiological reports can include those from specimens of blood, urine,other body fluids, skin, eyes, skeletal and other tissues. The PTdatabase 200 has the ability to store the subject specific informationas required within the CDPR 202.

The genotype specific or genetic disorder or disease data is retained inthe database 201 within the CDPR database 202. This data is eithersubject specific, family specific, breed specific, species specific,disorder specific, or disease specific, and is group or subjectspecific. The user can access the genotype database 201 and obtain aread-out 213 which can then be transmitted along line 214 to an output212 in the same manner that the physical health assessment is obtainedas an output.

In an alternative approach, the reader can request an analysis 215 fromthe genotype database as indicated by line 216. This analysis canreceive data along line 217 from the analysis information of thephysical health assessment. Interpretation of the PT and GT can beobtained as indicated by 218, and this can then be outputted asindicated along line 219. The interpretation of PT and GT 218 can beperformed by an algorithm relating to the coefficients andpredictability of information relating to disorders, disease andlongevity when considering the data from the two databases PT 200 and GT201. This can be done automatically and outputted along line 219, orthere can be an expert interface 220 using skilled personnel tointerpret the data of block 218, and this can, in turn, be outputtedalong line 221 to the output 212.

Database 207 can be a genetic marker database, and the information fromthat database can be directly input into the output through a read-out222 and 223 to the output 212. Alternatively, the data from database 207can be added to the interpretation section 218 of the physical healthand genetic information by directing the data along line 224. This datacan then be made the subject of the output along the line 219 and 221 asrequired.

Similarly other databases 208, 209, respectively, have read-outs 225 and226 which can be directly coupled along lines 227 and 228 to the output,or can be directed optionally along lines 229 and 230 to theinterpretation module 218. It can then be the subject of interpretationfor an expert interface 220 review which is, in turn, made the subjectof the output 219 and 221.

In each of the output lines 219, 221, 222, 223, 227, 228, and 214 thereis also provided an encryption program 231 which can be optionally usedin the system. The output 212 can include paper, electronic, or voiceread-out as is required.

In this manner, the output 212 provides a compilation which combines thephysical health and genetic information relating to a subject, thebreed, disease, disorder and lifespan, thereby enabling the receiver ofthe output 212 to use the compiled information in a manner to facilitatebreeding criteria which can be important in relation to animals whichare usually inbred or line bred. The information can also be used tofacilitate on-going monitoring of particular subject animals. The datafrom this system can be used to manipulate and regulate breeding,health, and longevity effectively among animals.

The system of the invention is further described with regard to FIG. 7which is a system for inputting data to the CDPR 202. Here multipleusers 203, which can be a remote user such as a laboratory, a breeder.an owner, hospital, agent, or an operator of the CDPR 202 accesses thesystem through module 204 which, in turn, accesses the CDPR 202.Appropriate access request and access enable messages are sent. Withinthe CDPR 202 there is a physical health or phenotype module 200, agenetic or genotype data module 201, and other database modules 207,etc. After accessing the CDPR 202, additional data can be added to themodules 200, 201, 207, etc. through any of the users 203, if authorized.Depositing data into each of the modules 200, 201 and 207 can optionallyrequire the payment to the operator of the CDPR 202 as is indicated byblock 205. This system can function in the same manner as the retrievalof data from CDPR 202.

The stored data in each of the blocks 200, 201, and 207 can be set up asindicated by block 232 in a manner which is restricted or unrestrictedto selected users 203. This may be necessary according to the protocolsgoverning the inputted data to the different databases. In some cases,the waiving of deposit fees is made in the interest of freedom of thedatabase to subsequent users who wish to retrieve data from thedatabase. After storage of the data as indicated by block 234, the user203 exits CDPR 202 as indicated by block 233.

As is apparent, the physical health or phenotype profile of subjectanimals is dynamic and grows as more data is added into the system.Likewise, the genetic genotype database also grows as increasingresearch of particular subjects, breeds, and the like is obtained. Thedeposit of new information into the CDPR 202 is regulated in a mannerthat the data cannot distort the databases 202 in an in appropriatemanner. Likewise, users 203 cannot access the secured databases withinCDPR 202 in an inappropriate manner.

Different algorithms regulate the relationship between the healthprofile, the genetic data, and other data relating to animals. Thesealgorithms determine the probabilities, possibilities, and likelihood ofdisorders and disease in subject animals and offspring animals. They areused as predictors of the future evolvement of health of the animal.

Exampt of Inter-Relationship and Algorithm Inter-Relationship of thePhenotype and Genotype Data Bases

In one example the genetic influence on behavior and behavioraldisorders accounts for less than half of the phenotypic expression ofbehavior and behavioral differences. However, behavior is the mostcomplex phenotype, because it reflects not only the functioning of thewhole being but also is dynamic and changes in response to environmentalinfluences. These results are most dramatically seen in purebred animalsbecause they have been inbred and line-bred to select for a particularbehavior and conformation, even though the genotype of purebred breedsshows almost no variation over 100 years. Examples of this are all thedifferent purebred dog breeds which currently exist, and have widelydisparate size, weight, temperament and lifespans.

Accordingly, if the results of a mostly phenotypic database indicateabnormal thyroid function, then by relating this to the mostly genotypicand combined database categories of breed, age and sex, it is possibleto determine whether the subject has or does not have heritable thyroiddisease, or is likely to develop this condition within a predictedperiod of time.

Similarly, if the phenotypic database indicates elevated blood and urineglucose levels, then by relating this to the genotypic and combineddatabase categories of weight, age, sex, breed and reproductive history,it is possible to determine that the subject has diabetes that is likelyto be of an heritable basis.

Another example relates the phenotypic database indicating low blood vonWillebrand factor level to the genotypic and combined databasecategories of breed, age, sex, and clinical and family history, wherebyit is possible to determine whether the subject has the inherited oracquired form of von Willebrand disease.

Analyzing the data from the CDPR 102 in the manner of the presentinvention permits for genetic screening, health assessment profiling,and the diagnostic, prophylactic, and therapeutic management of animals.

An exemplary server performs all the operations of a conventionaldatabase system and performs additional operations in accordance withthe present invention as has been discussed. The server includes acentral processing unit (CPU) together with associated memory forprocessing information about different animals species and history. Theinquiries concern animals species and history and inquiries and requestsfor health profiling and genetic information, and providing healthprofiles and genetic information. The CPU is coupled to the database andto users via a communications port. The CPU is also coupled to anelectronic mail processor for processing and storing (in a storagedevice) e-mail messages transmitted between the CPU and various agents,users and the like. The CPU is further coupled to a data storage device.A data storage device may include a variety of the databases. The systempermits for the requesting, storing and providing of data with respectto animal phenotypic information and genetic information. The format andcontent of the databases have been discussed in detail.

FIG. 8 presents an overview of the laboratory instruments apparatus,system, and method operable with the present invention in relation to aCDPR 202. The present invention allows access by remote users withcomputers or processors 100 to receive and access data on specimens.Using the Internet 6 or other computer network or communication linkcapability, the remote user 8 sends a message to request access to theservices provided by the laboratory or operator which has a CDPR 202. Ifaccess to the CDPR 202 is granted, a message is sent to the remote usercomputers 100. This message includes instructions enabling the remoteuser 8 to define and access data stored in the CDPR 202.

In one form of the invention, the desired data is based on thesubmission of test specimens of a specific animal to the laboratory. Insome other cases health profile test data 200 can be inputted into theCDPR 202 having the genetic database 201. The CDPR 202 can perform ananalysis and correlation between the health profile database 200 and thegenetic database 201.

Using the communications link, the remote user 8 communicates with thelaboratory or the CDPR 202. Specimens can be packaged and physicallytransported to the laboratory site via commercially available commoncarriers, such as the postal service or courier services. When thepackages arrive, the laboratory places them in storage, or the tests areperformed. Instruments 300 perform the tests to obtain data as specifiedby the remote user 8. The biohazardous samples can be disposed of awaste material. The test results, or output is provided as part of ahealth profile database 200 of the CDPR 202 and is available to theremote user 8.

If desired, the remote user 8 can arrange to have the data stored in theCDPR 202, made available to other remote users 8. The remote user 8 canalso request the laboratory to perform analysis on the health profiledata 200 generated.

In one embodiment, the communications link is a computer network and themessage transfer modality is, for instance, the Internet 6, and/or anIntranet and/or an Extranet. The network systems are particularly suitedto the application described herein since it offers global or widespreadaccessibility and high speed data transfer of large amounts ofinformation.

A security unit allows remote users to designate who has permission toview or use their data. Feasible options for these informationmanagement requirements include: access by the submitting remote usersonly, access by certain designated researchers and collaborators,timeembargoed data followed by wider access, and unrestricted access byall. A commerce unit can implement functions related to the businessaspects of the CDPR facility, including billing, inventory management ofsupport materials.

A multimedia unit comprises means to store, manipulate, and presentaudio, graphical, video information. This information may include avideo explaining how the CDPR is used, a visual depiction of the data,methodology, or a comment regarding the background of the data. Themultimedia unit may also implement subscription functions, so thatupdated data automatically provided to remote users or other interestedparties.

The operations performed by the present invention begins when thecontroller receives an access request message from the remote user via acommunication link. Using information in the access request message andany other available information, the controller determines if the remoteuser is authorized to access the CDPR 202. If so, an access enablingmessage is transmitted from the controller to the remote user 8. Theaccess enabling message can comprise a set of computer instructionstransmitted over the Internet 6 which is downloaded into the remote usermemory for execution by the remote user processor. These instructionsmay be enabling, that is, they may allow direct communication betweenthe remote user 8 and the CDPR 202 with no further need for thecontroller. In another embodiment, the access enabling message maysimply comprise a password or other enabling message which allows theremote user 8 to proceed. The remote user 8 can access or submit data tothe CDPR 202 according to different protocols and regimes and securityarrangements.

CONCLUSION

As is clear the tests above which relate to at least one of endocrinefunction, immunologic function, gastrointestinal function andnutritional analysis, metobolism, paternity, DNA fingerprinting,hemostasis and coagulation function, vaccinal antibody status, adversevaccine reaction, infectious disease, pathology, anatomic, histological,cytologic, immunohistochemical, electromicroscopy, FACS, blood typing,bone marrow analysis and immunohistochemical staining, and allergyreaction about the animal provide usefull information. This is in amanner previously not obtained.

As the above demonstrates, there is a need for providing data analysisand dissemination services to a wide variety of globally-distributedremote users. There is a need for providing a system for inputting,storing and retrieving data related to animal health assessment andgenetics in a manner which permits for the effective use of thisinformation.

The system also permits for the access to the genetic and/or phenotypedata through a password and a system whereby access to the datagenerates a fee. This system permits for the access or to provide datawith regard to credit cards or the like to ensure that the fee istransmitted automatically to a banking system for the account of thedatabase when such data is accessed.

This system also provides for a situation wherein payments can be madeby credit card for requests to perform health assessment profiles andsecure genomic mapping and genetic screening information. Suchbioinformatics system can also permit for the automatic payment for suchservices and products to the banking system of the database orlaboratory. As such, the database may require that the payments beguaranteed, for instance by supplying a credit card number with arequest for performance of services and a product, and for the retrievalof such data.

A user can submit a request to the database in any number of ways. Forexample, the request can be submitted via on-line direct connection,namely through a computer network such as the Internet. An intermediateresearcher such as a veterinarian or scientist other than the ownercould also submit the request on behalf of the owner using the e-mailcapabilities of the central database system. Alternatively, the user cansubmit the data via an interactive voice response unit coupled to thedatabase system of the supplier. In some situations, the databasesupplier can decide whether to supply the health assessment informationand/or genomic mapping and genetic screening information based on thecriteria of the user or its intermediary agent. Such user orintermediary agent can be notified of the decision via the interactiveresponse unit or a live operator.

The user or agent can log into the database system and obtain thenecessary records relating to an animal physical health and/or geneticancestry or offspring. The database system can transmit in real time oron a periodic basis as determined, thereby, providing informationregarding the health assessment or the genetic background and forwardthis information to the user and/or its intermediary agent.

The data storage devices of the invention include a variety of databasesincluding a database relating to the phenotypic data of a particularspecies, a database relating to health assessment or other phenotypicdata of particular animals in a particular species, and geneticcharacteristics of different species and different family trees relatingto different species. The family trees would contain informationincluding the origin, genomic map, and parental lines of a species andrecords of health and performance of a species. These databases areinterrelated in an analytical manner and in accordance with differentalgorithms of permutations and probabilities to facilitate useful outputinformation based on the combination of data in the genotypic and thephenotypic databases, and the selected databases.

Many other examples of the invention exist, each differing from othersin matters of detail only. The invention is to be determined solely bythe following claims.

REFERENCES

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What is claimed is:
 1. A veterinary diagnostic method of healthprofiling a selected subject animal to enhance the quality of life orextend the lifespan of the selected animal, the animal beingnon-livestock, comprising: a) obtaining the i) genetic data of theselected animal, the genetic data including at least one of the datarelating to genetic mapping, genetic background, or genetic screeningrelated to the selected animal; and ii) phenotype health assessment dataof the selected animal; b) using a computer program, combining thegenetic data and the phenotype health assessment data to determine arelationship between the genetic data and the phenotype healthassessment data; c) selecting from b) at least one of: i) the datarelating to the temperament of the selected animal; ii) the datarelating to the lifespan of the selected animal; or iii) a physiologicor genetic marker for autoimmune thyroiditis or thyroid dysfunction ofthe selected animal; and d) analyzing the selection of the data of c),the analysis including an evaluation of health, disease or disorderprobabilities to thereby enhance the quality of life or extend thelifespan of the selected animal, the selected animal being at least oneof a selected animal family, selected animal breed, selected animalgrouping, or selected animal species.
 2. The method of claim 1,including the steps of communicating between a remote user and a centraldatabase processing resource through a computer network, and providing areport of the analysis to the remote user after charging for suchreport.
 3. A method of claim 2, wherein the computer network is theInternet.
 4. A method of claim 1 comprising the step of analyzingbiological laboratory test data from a bodily fluid or a tissue of theselected animal, such test data being related to a neurotransmitteractivity of the animal.
 5. The method of claim 4, including obtainingdata related to at least one of the value of serotonin, thegamma-aminobutyric acid (GAB), the glutamate, the dopamine, the glycine,the aspartate, the acetylcholine, the norepinephrine, the histamine, thesubstance P, the vasopressin, the vasoactive intestinal peptide, theneurotensin, or the other neuropeptides of the animal.
 6. The method ofclaim 4, comprising the step of storing the report in a central databaseprocessing resource, including permitting a remote user to access thecentral database processing resource via a communications link, thecommunications link being a computer network, the access being forobtaining a report from the central database processing resource, thereport including the health profile of that animal.
 7. The method ofclaim 1 including obtaining additionally at least one of: iv) theneurotransmitter data relating to the temperament of the animal; v) theneurotransmitter data relating to the longevity of the animal; vi) dataassessing the bodily fluid and tissue immune stimulation reaction,neoplastic or paraneoplastic change, or cellular inflammatory responseof the animal; vii) metabolic marker of the animal for inherited organdysfunction or dysplasia; viii) data assessing the presence of orsusceptibility to mammary cancer of the animal; ix) data assessing theintegrity of immune surveillance mechanisms of the animal; or x) dataassessing the risk of inherited bleeding disease or disorder of theanimal.
 8. A method as claimed in claim 1 wherein the genetic data iscross-related to the phenotypic data.
 9. A veterinary diagnostic methodof health profiling a selected subject animal to enhance the quality oflife or extend the lifespan of the selected animal, the animal beingnon-livestock, comprising: a) obtaining the i) genetic data of theselected animal, the genetic data including at least one of the datarelating to genetic mapping, genetic background, or genetic screeningrelated to the selected animal; and ii) phenotype health assessment dataof the selected animal; b) using a computer program, combining thegenetic data and the phenotype health assessment data to determine arelationship between the genetic data and the phenotype healthassessment data; c) selecting from b) at least one of: i) the datarelating to the temperament of the selected animal; ii) the datarelating to the lifespan of the selected animal; or iii) a physiologicor genetic marker for autoimmune thyroiditis or thyroid dysfunction ofthe selected animal; and d) analyzing the selection of the data of c),the analysis including an evaluation of health, disease or disorderprobabilities and the nutrition of the selected animal, the selectedanimal being at least one of a selected animal family, selected animalbreed, selected animal grouping, or selected animal species.
 10. Amethod as claimed in claim 1 including using the combination of data tocreate a computer driven statistical model for predicting the occurrenceof disease, quality of life or a lifespan of an animal.
 11. A method asclaimed in claim 9 including using the combination of data to create acomputer driven statistical model for predicting the occurrence ofdisease, quality of life or a lifespan of an animal and the nutrition ofthe animal.
 12. The method of claim 9, including permittingcommunication of an access request message from a remote user via acommunications link, and the communications link being a computernetwork, the access request being for obtaining a report of theanalysis.
 13. A method of claim 12, wherein the computer network is theInternet.
 14. A method of claim 9 wherein the genetic data iscross-related to the phenotypic data.